Bi-Layer Tablet for Pain Relief with Reduced Adverse Effects

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Solution Overview

Problem

Available pain medications often cause adverse effects such as nausea, vomiting, and skin rashes, leading to intolerance of recommended dosages for effective pain relief, necessitating a need for therapeutics with reduced adverse effects.

Innovation Solution

A bi-layer tablet composition comprising an immediate release layer with promethazine and a controlled release layer with acetaminophen and hydrocodone, designed to provide rapid pain relief with minimized side effects, where the immediate release layer includes promethazine HCL, silicified microcrystalline cellulose, croscarmellose sodium, and magnesium stearate, and the controlled release layer includes acetaminophen, hydrocodone bitartrate, hydroxy methyl propyl cellulose, magnesium stearate, and stearic acid, optimizing the release profile for reduced adverse effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If recommended dosages of pain medications are administered, then effective pain relief is achieved, but adverse effects such as nausea, vomiting, and skin rashes occur

Engineering Contradiction:

Improvepain relief efficacyVSAvoidadverse effects

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent divides the pain relief function into two segments: immediate release promethazine for rapid onset pain relief and controlled release acetaminophen/hydrocodone for sustained pain management. This segmentation allows each component to address specific aspects of pain relief while managing adverse effects through controlled dosing schedules.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent utilizes different release parameters (immediate vs. controlled release) to modulate the pharmacokinetic profile of the medication. By changing the release rate parameter, the formulation achieves effective pain relief while reducing peak plasma concentrations that cause adverse effects like nausea and vomiting.

Inventive Principle:

Principle #35Parameter changes

2Speed

If immediate release formulation is used, then rapid pain relief is achieved, but sustained pain control is reduced

Engineering Contradiction:

Improvepain relief speedVSAvoidsustained pain control

Core Design Contradiction:

SpeedVSDuration of action of moving object

Solution Approach 1:

The patent merges two different release formulations into a single composite tablet: immediate release promethazine layer and controlled release acetaminophen/hydrocodone layer. This combination allows the immediate release component to provide rapid pain relief while the controlled release component ensures sustained pain control throughout the dosing interval.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The tablet is physically segmented into two distinct layers with different release characteristics. The immediate release layer addresses the speed requirement for rapid pain relief, while the controlled release layer addresses the duration requirement for sustained pain control, effectively resolving the contradiction between these two parameters.

Inventive Principle:

Principle #1Segmentation

3Duration of action of moving object

If controlled release formulation is used, then sustained pain control is improved, but rapid pain relief is reduced

Engineering Contradiction:

Improvesustained pain controlVSAvoidrapid pain relief speed

Core Design Contradiction:

Duration of action of moving objectVSSpeed

Solution Approach 1:

The formulation combines controlled release acetaminophen/hydrocodone with immediate release promethazine in a single tablet. The controlled release layer provides sustained pain control, while the immediate release promethazine layer compensates for the delayed onset of controlled release medications, ensuring rapid pain relief is achieved.

Inventive Principle:

Principle #5Merging (Combining)

4Reliability

If multiple medications are combined in one formulation, then therapeutic efficacy is improved, but formulation complexity increases

Engineering Contradiction:

Improvetherapeutic efficacyVSAvoidformulation complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The complex multi-drug formulation is segmented into distinct layers: an immediate release layer containing promethazine and a controlled release layer containing acetaminophen and hydrocodone. This physical segmentation simplifies the manufacturing process and allows for independent optimization of each drug's release characteristics while maintaining the therapeutic benefits of combination therapy.

Inventive Principle:

Principle #1Segmentation

Data Source

PatentUS10532030B2Pharmaceutical compositions for treating or preventing pain

Publication Date: 2020.01.14 LOCL PHARMA

AI summary

Methods and compositions are provided which comprise effective amounts of one or more analgesics, such as hydrocodone or acetaminophen, and an antiemetic, such as promethazine, to treat or prevent pain in a subject, and to reduce or prevent an adverse effect associated with the analgesics.